Adverse events in users of sertraline: results from an observational study in psychiatric practice in The Netherlands

Purpose To evaluate the safety profile of sertraline versus other Selective Serotonin Reuptake Inhibitors (SSRIs) directly following the introduction of sertraline to the Dutch market. Methods In a prospective follow-up study, 109 psychiatrists included patients with a new episode of treatment with sertraline and an equal number of patients starting treatment with other SSRIs. All Adverse Events (AEs) during follow-up were recorded by the psychiatrists for the duration of SSRI treatment until discontinuation or until at least 12 months. Results A total of 1251 patients were included in the study of which 659 used sertraline and 592 used other SSRIs (paroxetine, fluoxetine or fluvoxamine). The most frequently reported events in sertraline users and users of other SSRIs were nausea (160 (24.3%) sertraline patients versus 160 (27.0%) patients using other SSRIs), headache (127 (19.3%) sertraline patients versus 101 (17.1%) patients using other SSRIs), diarrhoea (94 (14.0%) sertraline patients versus 40 patients using other SSRIs (6.8%, p < 0.05)), sweating (88 (13.4%) sertraline patients versus 69 (11.7%) patients using other SSRIs) and dizziness (75 (11.4%) sertraline patients versus 70 (11.8%) patients using other SSRIs). A total of 121 patients reported 134 different unlabelled AEs of which 10 were reported by more than 1% of the population. Conclusions In this study we found that almost three out of four patients reported an adverse event. When comparing with other SSRIs and the literature, we found a similar distribution of the most frequently reported adverse events in patients using sertraline. However, in this observational study we found over 100 different unlabelled adverse events. Copyright (C) 2002 John Wiley Sons, Ltd.